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NOT YET RECRUITING
NCT07545759
PHASE2

A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Diarrhea (IBS-D)

Sponsor: Eli Lilly and Company

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate how well brenipatide (LY3537031) is tolerated, what side effects may occur, and the safety and efficacy in participants with Irritable Bowel Syndrome-Diarrhea (IBS-D). The study drug will be administered subcutaneously (SC) (under the skin) when compared with placebo. The study will last approximately 35 weeks.

Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Brenipatide in the Treatment of Adult Participants With IBS-D

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

531

Start Date

2026-04

Completion Date

2027-11

Last Updated

2026-04-22

Healthy Volunteers

No

Interventions

DRUG

LY3537031

Administered SC

DRUG

Placebo

Administered SC

Locations (88)

Del Sol Research Management - Mesa

Mesa, Arizona, United States

Smart Cures Clinical Research

Anaheim, California, United States

Om Research LLC

Lancaster, California, United States

United Medical Doctors - Los Alamitos

Los Alamitos, California, United States

Encore Medical Research

Hollywood, Florida, United States

Clinical Research of Osceola

Kissimmee, Florida, United States

Springfield Clinic - First

Springfield, Illinois, United States

Gastroenterology Health Partners

New Albany, Indiana, United States

Gastroenterology Health Partners

Louisville, Kentucky, United States

Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinical Research Center

Wyoming, Michigan, United States

Ohio Gastroenterology

Columbus, Ohio, United States

University Gastroenterology

Providence, Rhode Island, United States

Biopharma Informatic, LLC

McAllen, Texas, United States

Southern Star Research Institute

San Antonio, Texas, United States

Sint Vincentius Ziekenhuis

Antwerp, Belgium

AZ Sint-Lucas

Bruges, Belgium

UZ Brussel

Brussels, Belgium

Antwerp University Hospital

Edegem, Belgium

AZ Maria Middelares

Ghent, Belgium

AZ Sint-Lucas

Ghent, Belgium

UZ Gent

Ghent, Belgium

UZ Leuven

Leuven, Belgium

Clinical Chc Montlégia

Liège, Belgium

AZ Delta vzw

Roeselare, Belgium

Bluewater Clinical Research Group Inc.

Sarnia, Canada

Scarborough Center for Inflammatory Bowel Disease

Scarborough, Canada

ClinSurge Research - LMC Scarborough / Malvern Medical Centre

Scarborough, Canada

Stouffville Medical Research Institute Inc.

Stouffville, Canada

Canadian Phase Onward

Toronto, Canada

Binzhou Medical University Hospital

Binzhou, China

Sichuan Provincial People's Hospital

Chengdu, China

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, China

Zhejiang Hospital of Traditioal Chinese Medicine

Hangzhou, China

The Second Affiliated Hospital of University of South China

Hengyang, China

Huizhou Central People's Hospital

Huizhou, China

Huzhou Central Hospital

Huzhou, China

Meihekou Central Hospital

Meihekou, China

Quzhou People's Hospital

Quzhou, China

Taian City Central Hospital

Taian, China

Xianning Central Hospital

Xianning, China

Yichun People's Hospital

Yichun, China

FutureMeds GmbH

Berlin, Germany

Studienzentrum MVZ Dachau

Dachau, Germany

Klinische Forschung Hamburg

Hamburg, Germany

Klinische Forschung Karlsruhe

Karlsruhe, Germany

AmBeNet GmbH

Leipzig, Germany

Dedicated Research Site FutureMeds

Offenbach, Germany

Tokyo-Eki Center-building Clinic

Chūōku, Japan

Sai Gastroenterology/Proctology Clinic

Fujiidera, Japan

Tokai University Hospital

Isehara, Japan

Aoyama Internal Medicine Clinic

Kobe, Japan

Aono Clinic

Kobe, Japan

Hattori Clinic - Kumamoto

Kumamoto, Japan

Sapporo Odori Endoscope Clinic

Sapporo, Japan

Nishi-Shinjuku Kisaragi Clinic

Shinjuku-Ku, Japan

Scientia Investigacion Clinica Tj

Ciudad de Tijuana, Mexico

Investigación Clínica Cuernavaca, S.C.

Cuernavaca, Mexico

Clinica de Investigacion en Reumatologia y Obesidad S. C.

Guadalajara, Mexico

Proactive CR México SA de CV

Irapuato, Mexico

Centro de Investigación Clinica Chapultepec

Mexico City, Mexico

Hospital Juarez de Mexico

Mexico City, Mexico

Kohler & Milstein Research S.A. De C.V.

Mérida, Mexico

Clinical Research Institute S.C.

Tlalnepantla, Mexico

CIMAB SA de CV

Torreón, Mexico

Núcleo de Investigación Médica Sur de Guadalajara

Zapopan, Mexico

Gyncentrum sp. z o.o. NZOZ Holsamed - oddział Libero

Katowice, Poland

IRMED

Piotrkow Trybunalski, Poland

Twoja Przychodnia PCM

Poznan, Poland

Twoja Przychodnia SCM

Szczecin, Poland

WSD MEDI

Warsaw, Poland

Medical Network Spółka z o.o. WIP Warsaw IBD Point Profesor Kierkuś

Warsaw, Poland

ETG Zamość

Zamość, Poland

Hospital Universitari Vall d'Hebron

Barcelona, Spain

EAP Osona Sud - Alt Congost S.L.P

Centelles, Spain

Hospital Universitario Virgen Nieves

Granada, Spain

Hospital Clinico San Carlos

Madrid, Spain

Hospital Universitario Puerta de Hierro Majadahonda

Madrid, Spain

Hospital Costa del Sol

Marbella, Spain

Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca

Salamanca, Spain

Clínica Gaias - Santiago

Santiago de Compostela, Spain

Cheadle Community Hospital

Cheadle, United Kingdom

University Hospital of North Durham

Durham, United Kingdom

HMC Health Group - Meadows Centre for Health

Hounslow, United Kingdom

EMS Healthcare

Macclesfield, United Kingdom

Newquay Health Centre

Newquay, United Kingdom

Woodstock Bower Surgery

Rotherham, United Kingdom

Brockwood Medical Practice

Surrey, United Kingdom

King's Mill Hospital

Sutton in Ashfield, United Kingdom